<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20241007063276N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-11</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Effect  of Hypopressive exercises</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of adding hypopressive exercise to specific pelvic floor function  in semiprofessional female athletes</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/79411</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The sampling method is accessible, i.e. among semi-professional female athletes with pelvic floor disorders who are referred to the neuromuscular rehabilitation clinic of Semnan Rehabilitation Faculty to receive pelvic floor physiotherapy with the aim of managing the symptoms of pelvic floor disorders, those who consent to participate in the study and meet the entry criteria, they will be included in the study. Allocation to two groups is random and this allocation will be done using the randomized block method. For this purpose, two interventions A and B is considered in six blocks of ten as follows. When each patient enters, the physiotherapist will ask for the type of treatment from the relevant methodology. The methodologist, holding the prepared list below, chooses a number between one and six by throwing a dice, and in the selected block, selects the specified intervention (A or B) to The person is allocated and announced to the physiotherapist. In the next stages, if the selected block is filled, the dice throw is repeated, two other numbers are selected that the sequence of interventions has not yet been completed, and this work will continue until the end of all blocks and the completion of 60 cases, Blinding description: The study is one-sided blind. The evaluator in this study does not know the type of exercises of each person and is blind, the participant and the interventionist are fully present during the exercises and are not blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Low pressure exercises in stress urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: This group performs specific pelvic floor exercises that include pelvic floor contractions in standing and sitting positions and crouching with different rest and contraction times for eight weeks with weekly supervision by a physiotherapist. Intervention 2: Intervention group: Intervention group: This group performs specific pelvic floor exercises like the first group, and in addition, low pressure exercises are also performed along with it. They are performed with different rest and contraction times for eight weeks with the weekly supervision of a physiotherapist.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Investigating the effect of adding low pressure exercises to specific pelvic floor exercises on pelvic floor performance in semi-professional female athletes

When:
1404

To whom:
All people

Conditions:
Research and treatment projects

Where to obtain:
Rosita hedayati

How to obtain:
Statement of the subject of the research plan and occupational therapy

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rosita Hedayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Street, Semnan Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519856445</zip>
        <telephone>0233105</telephone>
        <email>Rosehed@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rosita Hedayati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Basij Street, Semnan Medical Sciences</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519844556</zip>
        <telephone>0233105</telephone>
        <email>Rosehed@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female athletes aged 18 to 60 despite symptoms of pelvic floor disorders lasting six months
More than a year has passed since giving birth
Exercising at least three days a week for more than a year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pregnancy six months before entering the study
Gynecological and urological surgeries
Age less than 18 and more than 60
Pelvic floor physiotherapy in the previous year
Neurological and psychiatric disease
Any medical prohibition to exercise
Inability to participate in subsequent evaluations
Inability to participate in subsequent evaluations
Undergoing hormone therapy
Irregularity in sports performance
Inability to properly contract the pelvic floor muscles
Inability to insert and maintain vaginal probe due to pain and discomfort</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female) (male)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: This group performs specific pelvic floor exercises that include pelvic floor contractions in standing and sitting positions and crouching with different rest and contraction times for eight weeks with weekly supervision by a physiotherapist.</i_keyword>
      <i_keyword>Intervention group: Intervention group: This group performs specific pelvic floor exercises like the first group, and in addition, low pressure exercises are also performed along with it. They are performed with different rest and contraction times for eight weeks with the weekly supervision of a physiotherapist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Endurance and strength of the pelvic floor muscles. Timepoint: At the beginning and after eight weeks of training. Method of measurement: Endurance and strength of the pelvic floor muscles with prineometer.</prim_outcome>
      <prim_outcome>Displacement of the base of the bladder. Timepoint: At the beginning and after eight weeks of training. Method of measurement: Using ultrasound.</prim_outcome>
      <prim_outcome>Stress urinary incontinence. Timepoint: At the beginning and after eight weeks of training. Method of measurement: One hour pad test.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the beginning and after eight weeks of training. Method of measurement: Quality of life questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-20</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Basij Boulevard, Semnan Medical Sciences Headquarters Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
